Provide Quality Engineering support to Urology & Neuromodulation Product Development, helping to ensure delivery of highest quality product to the customer on the next generation of Neuromodulation products. Develop, establish, and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Working in partnership with Urology & Neuromodulation Process Development group this person will support the introduction of new PCBA products & processes. Ensure Regulatory compliance in projects of responsibility by utilising quality tools and processes. Develop and/or review Process Qualifications, Test Method Validations, Gage R&R's, Process Capability studies, Design of Experiment (DOE), production control plans on new products. Coordinates and conducts technical investigation and documentation of non-conforming events and trends during the development & pilot phase on new products, and develop technical investigation plans using Engineering Essentials. Leads process improvement efforts by performing appropriate analysis methods to enhance sustaining product design and new product development. Create a strong team culture around high expectations & high performance with the Neuromodulation Production Unit team & the Process Development team. Identify & lead quality projects to support IPG Factory of the Future Production Area Strategy. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Provide clear communication to stakeholders at key technical updates Higher Level Hons Degree/Level 8 qualification in Engineering/Quality/Science with a minimum 5 years' experience in a Medical Device environment or related industry. Demonstrate strong leadership skills, communication skills and promote quality at source. Develop plans and execute on time to these plans. Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets. Experience/training in problem solving and process improvement methodologies (Engineering Essentials).
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